IMPORTANT SAFETY INFORMATION: WARNING: RISK OF ANAPHYLAXIS, HYPERSENSITIVITY AND IMMUNE-MEDIATED REACTIONS, AND RISK OF CARDIORESPIRATORY FAILURE If you or your child is taking Lumizyme, you should know that severe and potentially life-threatening allergic-type reactions known as anaphylaxis, severe hypersensitivity reactions, and reactions related to the immune system may occur during and after Lumizyme treatment. These reactions may include extreme difficulty breathing, shallow breathing, abnormal heart rate, low blood pressure, throat tightness, face and tongue swelling, kidney dysfunction, and severe skin lesions. You should seek immediate medical care if signs and symptoms of anaphylaxis, hypersensitivity reactions, and immune system reactions occur. View more

CHARITABLE ACCESS PROGRAM

The Sanofi Genzyme Charitable Access Program (CAP) has been established in the United States through the Genzyme Charitable Foundation, Inc. The program is committed to providing Lumizyme® to individuals who:

Medically need Lumizyme and

Are uninsured or have inadequate insurance coverage for Lumizyme

Qualified individuals with Pompe disease whose physicians have recommended treatment with Lumizyme may be eligible for the Charitable Access Program. If you are ineligible for our program, your CareConnectPSS Case Manager will work with you and your health care providers to explore alternative coverage options.

To be considered for the program, you will be asked to provide the following:

A Letter of Intent to Treat with Lumizyme. The letter must be on your doctor's letterhead. In this letter, your doctor will request charitable access to Lumizyme, including a rationale for charitable access.

A Statement of Medical Necessity from your physician

A completed program application

Your CareConnectPSS Manager will coordinate with you to obtain the necessary documentation, including a signed consent form.

Applications are reviewed on a monthly basis and are kept confidential by the Charitable Access Program Committee.

Please note that the Charitable Access Program is considered a temporary program. Patients and their families are expected to continue exploring alternative resources with the assistance of a CareConnectPSS Case Manager. These may include:

Private insurance

Government programs

To learn more about the Sanofi Genzyme's Charitable Access Program or to request an application form call 1-800-745-4447, option 3.

Disclaimer: the Sanofi Genzyme Charitable Access Program may be discontinued at anytime at the discretion of the Charitable Access Program Committee

Pompe Registry

Indication

Important Safety Information

WARNING: RISK OF ANAPHYLAXIS, HYPERSENSITIVITY AND IMMUNE-MEDIATED REACTIONS, AND RISK OF CARDIORESPIRATORY FAILURE

If you or your child is taking Lumizyme, you should know that severe and potentially life-threatening allergic-type reactions known as anaphylaxis, severe hypersensitivity reactions, and reactions related to the immune system may occur during and after Lumizyme treatment. These reactions may include extreme difficulty breathing, shallow breathing, abnormal heart rate, low blood pressure, throat tightness, face and tongue swelling, kidney dysfunction, and severe skin lesions. You should seek immediate medical care if signs and symptoms of anaphylaxis, hypersensitivity reactions, and immune system reactions occur. If such a reaction is severe enough, your doctor may decide to immediately discontinue the infusion and provide immediate medical care. Appropriate medical support measures may be administered during your infusion, and you may require close observation during and after Lumizyme administration.

If your child has compromised breathing or heart function due to Pompe disease, there may be a risk of acute worsening of heart and/or lung function with Lumizyme due to the fluid from the infusion, and your doctor may decide that close observation during and after Lumizyme administration may be necessary.

Warnings and Precautions

Anaphylaxis and Hypersensitivity Reactions: Life-threatening anaphylaxis and hypersensitivity reactions have been observed in some patients during and after treatment with alglucosidase alfa. If such a reaction is severe enough, your doctor may decide to immediately discontinue the infusion and provide you with immediate medical care. Appropriate medical support and monitoring measures should be available during infusion.

Immune-Mediated Reactions: You or your child may be monitored for the development of systemic immune-mediated reactions while receiving Lumizyme. If these reactions occur, your doctor may discontinue the infusion and initiate appropriate medical treatment.

Risk of Acute Cardiorespiratory Failure: Infant Pompe patients with heart or breathing
problems who are experiencing an acute respiratory condition may be at risk for increasing the seriousness of these problems as a result of Lumizyme administration due to the infusion fluid, and your child’s doctor may require additional monitoring for these infants.

Risk of Cardiac Arrhythmia and Sudden Cardiac Death during General Anesthesia for Central Venous Catheter Placement: Caution should be used when administering general anesthesia for the placement of a central venous catheter intended for Lumizyme infusion. Ventricular arrhythmias and slow heart rate resulting in cardiac arrest or death have been observed in infant Pompe patients with cardiac hypertrophy during general anesthesia for central venous catheter placement. Appropriate medical support and monitoring measures should be available during infusion.

Risk of Antibody Development: Patients with infantile-onset Pompe disease (IOPD) should be managed by a clinical specialist knowledgeable in immune tolerance induction in Pompe disease to optimize treatment. Some patients who develop high and sustained IgG antibody levels, including certain IOPD patients, may have a reduced response to Lumizyme.

Monitoring: Laboratory Tests: Patients should be monitored for IgG antibody formation every 3 months for 2 years and then annually thereafter.

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